Trial Outcomes & Findings for Blood Lactate Concentrations With and Without Exercise in Parkinson's Disease and Multiple Sclerosis Patients (NCT NCT02184494)
NCT ID: NCT02184494
Last Updated: 2017-03-30
Results Overview
Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Before, immediately after, and 10 minutes after the squatting exercise protocol
Results posted on
2017-03-30
Participant Flow
Participant milestones
| Measure |
Blood Lactate Response in PD
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Response in MS
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Responses in Healthy, Older Adults
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
8
|
|
Overall Study
COMPLETED
|
12
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blood Lactate Concentrations With and Without Exercise in Parkinson's Disease and Multiple Sclerosis Patients
Baseline characteristics by cohort
| Measure |
Blood Lactate Response in PD
n=12 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Response in MS
n=11 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Responses in Healthy, Older Adults
n=8 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 9 • n=5 Participants
|
52 years
STANDARD_DEVIATION 10 • n=7 Participants
|
50 years
STANDARD_DEVIATION 10 • n=5 Participants
|
59 years
STANDARD_DEVIATION 14 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
8 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Before, immediately after, and 10 minutes after the squatting exercise protocolPopulation: 2 of the 8 participants in the healthy, older adults group did not return for this visit, and thus, were not included in analysis. 1 of the 12 MS participants did not return for this visit, and thus, were not included in analysis.
Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise
Outcome measures
| Measure |
Blood Lactate Response in PD
n=12 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Response in MS
n=11 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Responses in Healthy, Older Adults
n=6 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
|---|---|---|---|
|
Blood Lactate Response
Pre without Whole Body Vibration
|
1.7 mmol/L
Standard Deviation 0.7
|
1.6 mmol/L
Standard Deviation 0.7
|
1.2 mmol/L
Standard Deviation 0.4
|
|
Blood Lactate Response
Immediately Post without Whole Body Vibration
|
2.3 mmol/L
Standard Deviation 0.9
|
2.8 mmol/L
Standard Deviation 1.3
|
2.5 mmol/L
Standard Deviation 1.1
|
|
Blood Lactate Response
10 Minutes Post without Whole Body Vibration
|
2.2 mmol/L
Standard Deviation 1.3
|
3.3 mmol/L
Standard Deviation 2.3
|
2.6 mmol/L
Standard Deviation 1.2
|
|
Blood Lactate Response
Pre with Whole Body Vibration
|
1.8 mmol/L
Standard Deviation 0.7
|
2.2 mmol/L
Standard Deviation 1.0
|
1.3 mmol/L
Standard Deviation 0.3
|
|
Blood Lactate Response
Immediately Post with Whole Body Vibration
|
3.1 mmol/L
Standard Deviation 2.4
|
4.3 mmol/L
Standard Deviation 3.0
|
2.9 mmol/L
Standard Deviation 0.9
|
|
Blood Lactate Response
10 Minutes Post with Whole Body Vibration
|
1.8 mmol/L
Standard Deviation 0.5
|
3.1 mmol/L
Standard Deviation 1.9
|
2.2 mmol/L
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.Population: 1 of the 12 PD participants had severe claustrophobia, and could not tolerate the breathing mask on their face. 1 of the 12 PD participants, and 1 of the 8 healthy, older adults participants: dysfunctional equipment, and thus invalid results.
Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.
Outcome measures
| Measure |
Blood Lactate Response in PD
n=10 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Response in MS
n=11 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Responses in Healthy, Older Adults
n=7 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
|---|---|---|---|
|
Resting Energy Expenditure
|
1338 kcal
Standard Deviation 284
|
1262 kcal
Standard Deviation 139
|
1521 kcal
Standard Deviation 276
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes.Population: The MS and healthy, older adults populations were not required to be assessed with the UPDRS because the assessment materials were for PD populations, specifically.
Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.
Outcome measures
| Measure |
Blood Lactate Response in PD
n=12 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Response in MS
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Responses in Healthy, Older Adults
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
|---|---|---|---|
|
Neurological Function
|
23 units on a scale
Standard Deviation 6
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected immediately after the UPDRS (if PD population), or immediately after the resting energy expenditure measurement (if MS or healthy, older adult). Measured with other questionnaires and immediately before squatting exercise. Lasted ~10 minutes.Population: 2 of the 8 healthy, older adults did not complete all of the surveys, and were thus, clearly unable to be added to analysis.
Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant's degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant's ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence.
Outcome measures
| Measure |
Blood Lactate Response in PD
n=12 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Response in MS
n=11 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Responses in Healthy, Older Adults
n=6 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
|---|---|---|---|
|
Health and Activity Questionnaire
Physical Funcitoning
|
65 units on a scale
Standard Deviation 21
|
66 units on a scale
Standard Deviation 22
|
95 units on a scale
Standard Deviation 4
|
|
Health and Activity Questionnaire
Role Limitations due to Physical Health
|
43 units on a scale
Standard Deviation 34
|
70 units on a scale
Standard Deviation 32
|
82 units on a scale
Standard Deviation 35
|
|
Health and Activity Questionnaire
Role Limitations due to Emotional Health
|
73 units on a scale
Standard Deviation 34
|
82 units on a scale
Standard Deviation 26
|
90 units on a scale
Standard Deviation 23
|
|
Health and Activity Questionnaire
Energy/Fatigue
|
55 units on a scale
Standard Deviation 17
|
42 units on a scale
Standard Deviation 26
|
71 units on a scale
Standard Deviation 21
|
|
Health and Activity Questionnaire
Emotional Well-Being
|
75 units on a scale
Standard Deviation 16
|
75 units on a scale
Standard Deviation 13
|
87 units on a scale
Standard Deviation 5
|
|
Health and Activity Questionnaire
Social Functioning
|
78 units on a scale
Standard Deviation 20
|
73 units on a scale
Standard Deviation 22
|
95 units on a scale
Standard Deviation 13
|
|
Health and Activity Questionnaire
Pain
|
73 units on a scale
Standard Deviation 16
|
70 units on a scale
Standard Deviation 29
|
86 units on a scale
Standard Deviation 8
|
|
Health and Activity Questionnaire
General Health
|
68 units on a scale
Standard Deviation 19
|
58 units on a scale
Standard Deviation 15
|
87 units on a scale
Standard Deviation 8
|
|
Health and Activity Questionnaire
Activities of Daily Living
|
85 units on a scale
Standard Deviation 5
|
NA units on a scale
Standard Deviation NA
Participants in this group did not complete this survey.
|
100 units on a scale
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes.Population: 2 of the 8 healthy, older adults did not complete all of the surveys, and were thus unable to be added to analysis.
Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms. Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms.
Outcome measures
| Measure |
Blood Lactate Response in PD
n=12 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Response in MS
n=11 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
Blood Lactate Responses in Healthy, Older Adults
n=6 Participants
This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
|
|---|---|---|---|
|
Fatigue/Depression Assessment
Depression
|
7 units on a scale
Standard Deviation 5
|
8 units on a scale
Standard Deviation 5
|
3 units on a scale
Standard Deviation 3
|
|
Fatigue/Depression Assessment
Fatigue
|
30 units on a scale
Standard Deviation 18
|
38 units on a scale
Standard Deviation 17
|
17 units on a scale
Standard Deviation 14
|
Adverse Events
Blood Lactate Response in PD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Blood Lactate Response in MS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Blood Lactate Responses in Healthy, Older Adults
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place